Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

NCT07354841 | Recruiting

• 2 other identifiers: DE-62-22CIV-IT-25-03-051856
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety. Phase 2 is a pivotal study aimed at confirming safety and evaluating efficacy through comparison with Medtronic cannulas (control group). The results will be compared for non-inferiority with those obtained using the control group cannulas.

Conditions

Cardiac Surgery; Heart Surgery; Cardiopulmonary Bypass; Coronary Surgery; Aortic Valve Surgery; Cannulation; Venous Cannulation; Arterial Cannulation; Coronary Surgery With Cardiopulmonary Bypass

Keywords

Arterial Cannula; Venous Cannula; Extracorporeal Circulation; Cardiopulmonary Bypass; Cardiac Surgery; Medical Device; Device Safety; Device Performance; Aortic Valve Surgery; Coronary Surgery; Two Phases clinical investigation; Monocentric Study; Two Phases Study; Serious Adverse Events (SAE); CVP; NIRS; Venous Cannula Drainage Pressure; Arterial Cannula Reinfusion Pressure

Outcome Measures

Primary Outcomes (3)

• Phase 1: Safety of Eurosets Arterial and Venous Cannulas

  Number and type of adverse events over the duration of the investigation.

  At Visit 1 (Pre and during surgical procedure), at Visit 2 (24 hours post-surgical procedure) and at Visit 3 (within 6-7 days post-surgical procedure)

• Phase 2: Performance of Eurosets Arterial Cannulas

  For Arterial cannula: the performance of the Eurosets Arterial Cannulacerebral oximetry (rSO2) will be monitored during CPB using near infrared spectroscopy (NIRS). Delta rSO2 (will be calculated as the percentage) (rate of decrease of rSO2 from pre-clamping) will be compared to delta rSO2 of control arterial cannula.

  Time points during CPB: 1st: pre-clamping/CPB initiation, 2nd: pre-weaning

• Phase 2: Performance of Eurosets Venous Cannulas

  For Venous cannula: the performance of the Eurosets Venous Cannula, Central Venous Pressure (CVP) values will be monitored during CPB. Results will be compared to control venous cannula.

  Time points during CPB: 1st: pre-clamping/CPB initiation (full flow), 2nd: 10 minutes post-clamping, 3rd: 30 minutes post-clamping.

Secondary Outcomes (48)

• Phase 1: Clinical Parameters collected for safety: pH

  At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

• Phase 1: Clinical Parameters collected for safety: pCO2

  At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

• Phase 1: Clinical Parameters collected for safety: pO2

  At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

• Phase 1: Clinical Parameters collected for safety: Blood Flow

  At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

• Phase 1: Clinical Parameters collected for safety: Mean arterial pressure (MAP)

  At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

Other Outcomes (17)

• Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pH

  At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

• Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pCO2

  At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

• Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pO2

  At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

Study Arms (2)

Eurosets Arterial and Venous Cannula

EXPERIMENTAL

Phase 1: All enrolled subjects will undergo cardiopulmonary bypass using the investigational Eurosets arterial and venous cannulas to evaluate the safety. Phase 2: Participants will undergo cardiopulmonary bypass using the investigational Eurosets arterial and venous cannulas to confirm safety and to evaluate the performance.

Device: Eurosets Venous and Arterial Cannula

Control Arterial and Venous Cannula

ACTIVE COMPARATOR

Phase 2: Participants will undergo cardiopulmonary bypass using commercially available arterial and venous cannulas currently used in standard clinical practice.

Device: Control Arterial and Venous Cannulas

Interventions

Eurosets Venous and Arterial Cannula DEVICE

Phase 1: Use of investigational Eurosets arterial and venous cannulas during CPB to assess safety and preliminary performance.The Arterial cannulae are designed for insertion in the ascending Aorta. For this Investigation the arterial cannula is reinforced-long curved with flange tip, 3/8" connector with luer lock, 24 Fr.The Venous Cannulae are designed to be used for vena cava and right atrium blood drainage during CPB surgery. For this Investigation the venous cannula is dual stage without connector, lighthouse tip, 32/40 Fr. Phase 2: Use of investigational PVC arterial and venous cannulas during cardiopulmonary bypass (CPB) to confirm safety and evaluate performance compared to control group. For Investigation device: same of phase 1. For Control Group: the Arterial Cannula is EOPA (Medtronic), 24 Fr; the Venous Cannula is Two stage MC2 (Medtronic), 32/40 Fr.

Eurosets Arterial and Venous Cannula

Control Arterial and Venous Cannulas DEVICE

Phase 2: Use of commercially available arterial and venous cannulas as comparator devices to evaluate the performance of the investigational PVC Arterial and Venous Cannulas during cardiopulmonary bypass (CPB) procedures. the control cannulas are EOPA 24Fr (Medtronic) as Arterial Cannula and Two Stage MC2 32/40Fr (Medtronic) as Venous Cannula.

Control Arterial and Venous Cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is considered able and willing to provide written informed consent according to the ethically approved informed consent form;
• Female and male patients aged ≥ 18;
• Body weight between 60 and 120 kg;
• Body surface area (BSA) between 1.5 and 2.5 m2;
• Patients scheduled to undergo central cannulation for cardiopulmonary bypass (CPB) in elective surgery procedures (isolated coronary and/or aortic valve surgery).

You may not qualify if:

• Emergency cases;
• Re-do cardiac surgery procedure;
• Diabetes mellitus;
• Hematologic diseases or history of thrombophilia;
• Pregnancy or breastfeeding;
• Concomitant major cardiac procedures;
• Active malignant/metastatic neoplasm of any type;
• Presence of pneumothorax and/or pulmonary emphysema;
• Significant central nervous system injury;
• Current intracranial hemorrhage;
• Immunosuppression;
• Contraindication for therapeutic anticoagulation (e.g., heparin);
• Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;
• Abnormal or pathological cannulation site;
• Uncontrolled active bleeding;

Sponsors & Collaborators

• Eurosets S.r.l.: lead

Study Sites (1)

Anthea Hospital GVM Care & Research

Bari, BA, 70124, Italy

RECRUITING

Related Publications (7)

• Ismail A, Semien G, Sharma S, Collier SA, Miskolczi SY. Cardiopulmonary Bypass. 2024 Aug 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482190/

  PMID: 29489210 RESULT

• von Segesser LK, Ferrari E, Delay D, Maunz O, Horisberger J, Tozzi P. Routine use of self-expanding venous cannulas for cardiopulmonary bypass: benefits and pitfalls in 100 consecutive cases. Eur J Cardiothorac Surg. 2008 Sep;34(3):635-40. doi: 10.1016/j.ejcts.2008.05.037. Epub 2008 Jul 16.

  PMID: 18635371 RESULT

• Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.

  PMID: 28970635 RESULT

• Authors/Task Force Members; Kunst G, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Puis L, Wahba A; EACTS/EACTA/EBCP Committee Reviewers; Alston P, Fitzgerald D, Nikolic A, Onorati F, Rasmussen BS, Svenmarker S. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Br J Anaesth. 2019 Dec;123(6):713-757. doi: 10.1016/j.bja.2019.09.012. Epub 2019 Oct 2. No abstract available.

  PMID: 31585674 RESULT

• Lamelas J, Aberle C, Macias AE, Alnajar A. Cannulation Strategies for Minimally Invasive Cardiac Surgery. Innovations (Phila). 2020 May/Jun;15(3):261-269. doi: 10.1177/1556984520911917. Epub 2020 May 21.

  PMID: 32437215 RESULT

• Narasaki S, Miyoshi H, Nakamura R, Sumii A, Watanabe T, Otsuki S, Tsutsumi YM. Venous cannula occlusion during cardiopulmonary bypass recognized by ultrasonography of the internal jugular vein. JA Clin Rep. 2022 Apr 12;8(1):29. doi: 10.1186/s40981-022-00519-2.

  PMID: 35412158 RESULT

• Wahba A, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Kunst G, Puis L; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):210-251. doi: 10.1093/ejcts/ezz267. No abstract available.

  PMID: 31576396 RESULT

Related Links

• \[Yichao et al., 2006\] Yichao Teng, HaiShu Ding, Qingcheng Gong, Zaishen Jia, Lan Huang, "Monitoring cerebral oxygen saturation during cardiopulmonary bypass using near-infrared spectroscopy: the relationships with body temperature and perfusion rate," J.

Central Study Contacts

Prof. Giuseppe Nasso

CONTACT

+39 080 5644111; gnasso@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1: Pilot, not Randomized, Monocentric one arm Clinical Investigation with pre-market medical device Phase 2: Pivotal, Randomized, Non-inferiority, Monocentric, two arm Clinical Investigation with pre-market medical device

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: January 21, 2026
• Study Start: October 21, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

IT (1)